Study Number of patients Study design Results Conclusion
Arellano et al. (2007) (68)
293,253
Nested case-control study (US PharMetrics database) Adjusted OR for lymphoma: pimecrolimus vs non-use: 0.82 (95% CI 0.42-1.61) tacrolimus vs non-use: 0.79 (95% CI 0.37-1.71) low-potency TCS vs non-use: 1.06 (95% CI 0.72-1.57) high-potency TCS vs non-use: 1.23 (95% CI 0.83-1.84)
No increased risk of lymphoma in patients treated with TCS or TCIs, including pimecrolimus
Arana et al. (2011) (72)
625,915
Nested case-control study (US PharMetrics database) Adjusted OR for lymphoma: pimecrolimus vs non-use: 0.76 (95% CI 0.54-1.08) tacrolimus vs non-use: 1.24 (95% CI 0.80-1.91) TCS vs non-use: 0.90 (95% CI 0.75-1.07)
No increased risk of overall lymphoma in patients with AD treated with TCS or TCIs, including pimecrolimus. No difference in patients below the age of 20 years
Schneeweiss et al. (2009) (69)
1,200,645
Nested case-control study (US Ingenix database)
RR for lymphoma: pimecrolimus vs non-use: 1.79 (95% CI 0.92-3.48) pimecrolimus vs tacrolimus: 1.16 (95% CI 0.74-1.82) pimecrolimus vs TCS: 1.15 (95% CI 0.49-2.72)
No increased risk of lymphoma with pimecrolimus compared to untreated patients or compared to patients treated with tacrolimus or TCS
Arellano et al. (2009) (70)
3,500,194
A nested case-control study (UK THIN database) OR for lymphoma: patients with AD vs patients without AD: 1.83 (95% CI, 1.41-2.36) TCS vs non-use: 1.46 (95% CI 1.33-1.61) high-potency TCS vs non-use: 1.80 (95% CI 1.54-2.11) low-potency TCS vs non-use: 1.36 (95% CI 1.22-1.51)
Increased risk of lymphoma in patients with AD, especially severe AD. TCS use associated with increased risk for lymphoma. No cases of lymphoma identified in TCI users but number of patients using TCIs was too low to determine OR
Hui et al. (2009) (74)
953,064
Retrospective cohort study (US Kaiser Permanente database)
Adjusted HR for cancer: pimecrolimus vs non-use: 1.15 (95% Cl 0.99-1.31) tacrolimus vs non-use: 0.93 (95% CI 0.81-1.07) Adjusted HR for T-cell lymphoma: pimecrolimus vs non-use: 2.32 (95% CI 0.89-6.07) tacrolimus vs non-use: 5.44 (95% CI 2.51-11.79)
No increase of overall cancer rate with exposure to tacrolimus or pimecrolimus. No increased risk of T-cell lymphoma with pimecrolimus. Use of tacrolimus may be associated with increased risk of T-cell lymphoma